BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2014173 · Received March 10, 2011

    Report

    Report Number
    2649622-2011-03189
    Event Type
    Death
    Date Received
    March 10, 2011
    Date of Event
    February 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE CUT, THE OUTER INSULATION WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS FURTHER NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE CUT, THE OUTER INSULATION WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS FURTHER NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL ANALYSIS ONLY WAS PERFORMED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME FOLLOWING THE PATIENTS DEATH. THE CAUSE OF DEATH HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death